Multi-actuating trigger anchor delivery system

ABSTRACT

A single trigger system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for such purposes.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of copending U.S. patentapplication Ser. No. 11/671,914, entitled Integrated Handle Assembly ForAnchor Delivery System, filed Feb. 6, 2007, which is acontinuation-in-part of copending U.S. patent application Ser. No.11/492,690, entitled Apparatus and Method for Manipulating or RetractingTissue and Anatomical Structure, filed on Jul. 24, 2006, which is acontinuation-in-part of copending U.S. patent application Ser. No.11/318,246, entitled Devices, Systems and Methods for Retracting,Lifting, Compressing, Supporting or Repositioning Tissues or AnatomicalStructures, filed on Dec. 22, 2005, which is a continuation-in-part ofcopending U.S. patent application Ser. No. 11/134,870 entitled Devices,Systems and Methods for Treating Benign Prostatic Hyperplasia and OtherConditions, filed on May 20, 2005, the entire disclosures of which areexpressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to systems and associated methods for manipulatingor retracting tissues and anatomical or other structures within the bodyof human or animal subjects for the purpose of treating diseases ordisorders and/or for cosmetic or reconstructive or other purposes.

BACKGROUND OF THE INVENTION

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., organs, ligaments, tendons, muscles,tumors, cysts, fat pads, etc.) within the body of a human or animalsubject. Such procedures are often carried out for the purpose oftreating or palliating the effects of diseases or disorders (e.g.,hyperplasic conditions, hypertrophic conditions, neoplasias, prolapses,herniations, stenoses, constrictions, compressions, transpositions,congenital malformations, etc.) and/or for cosmetic purposes (e.g., facelifts, breast lifts, brow lifts, etc.) and/or for research anddevelopment purposes (e.g., to create animal models that mimic variouspathological conditions). In many of these procedures, surgicalincisions are made in the body and laborious surgical dissection isperformed to access and expose the affected tissues or anatomicalstructures. Thereafter, in some cases, the affected tissues oranatomical structures are removed or excised. In other cases, variousnatural or man made materials are used to lift, sling, reposition orcompress the affected tissues.

Benign Prostatic Hyperplasia (BPH)

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa Repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1a-adrenergic receptors blockersblock that activity of alpha-1a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1a-adrenergic receptorscauses prostatic smooth muscle relaxation. This in turn reduces urethralresistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todihydrotestosterone. Dihydrotestosterone causes growth of epithelialcells in the prostate gland. Thus 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and hence reducethe volume of the prostate gland which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethal Resection of Prostate (TURP) is the most commonly practicedsurgical procedure implemented for the treatment of BPH. In thisprocedure, prostatic urethral obstruction is reduced by removing most ofthe prostatic urethra and a sizeable volume of the surrounding prostategland. This is carried out under general or spinal anesthesia. In thisprocedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus the region of urethra that is blocked bythe surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases are deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam etc.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, aneodymium:yttrium-aluminum-garnet (Nd:YAG) laser is used to ablatetissue by causing coagulation necrosis. The procedure is performed undervisual guidance. In HoLEP, a holmium:Yttrium-aluminum-garnet laser isused for direct contact ablation of tissue. Both these techniques areused to remove tissue obstructing the urethral passage to reduce theseverity of BPH symptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is thePotassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser ishighly absorbed by oxyhemoglobin. This laser vaporizes cellular waterand hence is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate glandthus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which in turn causes the prostate gland toshrink. Shrinkage of the prostate gland reduces the degree of squeezingof the urethra by the prostate thus reducing the severity of BPHsymptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have disadvantages. Alpha-1a-adrenergic receptorsblockers have side effects such as dizziness, postural hypotension,lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculationcan also occur. 5-alpha-reductase inhibitors have minimal side effects,but only a modest effect on BPH symptoms and the flow rate of urine. Inaddition, anti-androgens, such as 5-alpha-reductase, require months oftherapy before LUTS improvements are observed. Surgical treatments ofBPH carry a risk of complications including erectile dysfunction;retrograde ejaculation; urinary incontinence; complications related toanesthesia; damage to the penis or urethra, need for a repeat surgeryetc. Even TURP, which is the gold standard in treatment of BPH, carriesa high risk of complications. Adverse events associated with thisprocedure are reported to include retrograde ejaculation (65% ofpatients), post-operative irritation (15%), erectile dysfunction (10%),need for transfusion (8%), bladder neck constriction (7%), infection(6%), significant hematuria (6%), acute urinary retention (5%), need forsecondary procedure (5%), and incontinence (3%) Typical recovery fromTURP involves several days of inpatient hospital treatment with anindwelling urethral catheter, followed by several weeks in whichobstructive symptoms are relieved but there is pain or discomfort duringmicturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries have made their removal quite difficult andinvasive.

Thus the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

Urinary Incontinence (UI)

Many women experience loss of bladder control following childbirth or inold age. This condition is broadly referred to as urinary incontinence(UI). The severity of UI varies and, in severe cases, the disorder canbe totally debilitating, keeping the patient largely homebound. It isusually associated with a cystocele, which results from sagging of theneck of the urinary bladder into or even outside the vagina

The treatments for UI include behavioral therapy, muscle strengtheningexercises (e.g., Kegel exercises), drug therapy, electrical stimulationof the pelvic nerves, use of intravaginal devices and surgery.

In severe cases of UI, surgery is generally the best treatment option.In general, the surgical procedures used to treat UI attempt to lift andsupport the bladder so that the bladder and urethra are returned totheir normal positions within the pelvic cavity. The two most commonways of performing these surgeries is through incisions formed in theabdominal wall or though the wall of the vagina.

A number of different surgical procedures have been used to treat UI.The names for these procedures include the Birch Procedure,Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling, Trans-VaginalTape Procedure, Urethral Suspension, Vesicourethral Suspension. Theseprocedures generally fall into two categories, namely a) retropubicsuspension procedures and b) sling procedures.

In retropubic suspension procedures, an incision is typically made inthe abdominal wall a few inches below the navel and a network ofconnectors are placed to support the bladder neck. The connectors areanchored to the pubic bone and to other structures within the pelvis,essentially forming a cradle which supports the urinary bladder.

In sling procedures, an incision is typically made in the wall of thevagina and a sling is crafted of either natural tissue or synthetic(man-made) material to support the bladder neck. Both ends of the slingmay be attached to the pubic bone or tied in front of the abdomen justabove the pubic bone. In some sling procedures a synthetic tape is usedto form the sling and the ends of the synthetic tape are not tied butrather pulled up above the pubic bone.

The surgeries used to treat UI are generally associated with significantdiscomfort as the incisions heal and may require a Foley or supra-pubicurinary catheter to remain in place for at least several days followingthe surgery. Thus, there exists a need in the art for the development ofminimally invasive (e.g., non-incisional) procedures for the treatmentof UI with less postoperative discomfort and less requirement forpost-surgical urinary catheterization.

Cosmetic or Reconstructive Tissue Lifting and Repositioning

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, etc. havebecome commonplace. In many cases, these procedures are performed bycreating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, other muscles) to hold the repositioned tissuesin their new (e.g., lifted) position. In some cases excess skin may alsobe removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,connector suspension lifts have been developed where one end of astandard or modified connector thread is attached to muscle and theother end is anchored to bone, periostium or another structure to liftand reposition the tissues as desired. Some of these connectorsuspension techniques have been performed through cannulas or needlesinserted though relatively small incisions of puncture wounds.

There remains a need for the development of new devices and methods thatmay be used for various procedures where it is desired to lift,compress, support or reposition tissues or organs within the body withless intraoperative trauma, less post-operative discomfort and/orshorter recovery times. Further, there is a need for an apparatus andrelated method which is easy and convenient to employ in aninterventional procedure. In particular, there is a need for asubstantially automated apparatus which can accomplish accessing aninterventional site as well as the assembly and delivery of aninterventional device at the site.

The present invention addresses these and other needs.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention is directed towardsan apparatus and method for deploying an anchor assembly within apatient's body. The apparatus of the present invention includes varioussubassemblies which are mobilized via a multi-actuating trigger. Theoperation of the subassemblies is coordinated and synchronized tominimize operator steps and to ensure accurate and precise implantationof a single or multiple anchor assemblies.

In one embodiment, the multi-actuating trigger anchor delivery system ofthe present invention includes a handle assembly operatively connectedto a core assembly. The handle assembly can be permanently connected tothe core assembly or the core assembly can be attachable to the handleassembly such that the handle can be used with multiple core assembliesover time. The core assembly houses a plurality of components forconstructing anchor assemblies. The handle assembly further includes arocker arm assembly, a spool or rotary assembly and a trigger assemblywhich cooperate to accomplish the various functions of the deliverysystem. In particular, in one aspect the spool assembly includes one ormore spring assemblies loaded with sufficient energy to advance anddeploy components for multiple anchor assemblies. The spool assembly isparticularly advantageous in that it allows several anchor assemblies ofat least 6 cm of length each to be stored in a relatively small devicethat fits in a user's hand. It is further advantageous in that it allowsthe physician to insert the device only once into the patient to delivermultiple anchor assemblies at different locations before having towithdraw the device. In another aspect the rocker arm assembly includesone or more spring assemblies loaded with sufficient energy to advanceand retract the core assembly a plurality of times. The delivery systemfurther includes a reset assembly that may recharge one or more springswithin the handle and core assemblies. It can be appreciated that rockerarm and spool housing actuation can be accomplished by manualadvancement, elastomers, compressed gas, or motor.

In one particular aspect, the present invention is directed towards adelivery device which accomplishes the delivery of a first or distalanchor assembly component at a first location within a patient's bodyand the delivery of a second or proximal anchor assembly component at asecond location within the patient. The device also accomplishesimparting a tension during delivery and a tension between implantedanchor components as well as cutting the anchor assembly to a desiredlength and assembling the proximal anchor in situ. The procedure can beviewed employing a scope incorporated into the device. Also, thedelivery device can be sized and shaped to be compatible with a sheathin the range of 18 to 24 F, preferably a 19 F sheath.

Additionally, in a contemplated embodiment of a multi-actuating triggeranchor delivery system, a first trigger pull results in a needleassembly being advanced within a patient to an interventional site. Asecond trigger pull accomplishes the deployment of a first anchorcomponent of an anchor assembly at the interventional site and a thirdtrigger pull facilitates withdrawing the needle assembly. A fourthtrigger depression facilitates the assembly and release of a secondcomponent of an anchor assembly at the interventional site. A resetassembly is further provided to reset aspects of the delivery system.

The present invention also contemplates a reversible procedure as wellas an anchor assembly with sufficient visibility when viewedultrasonically, by xray, MRI or other imaging modalities. In one aspect,the implant procedure is reversible by severing a connector of an anchorassembly and removing an anchor of the anchor assembly such as by soremoving a proximally placed anchor previously implanted in an urethra.Moreover, the anchor assemblies can be formed of structures facilitatingultrasound viewing or other imaging modalities.

The anchor assembly can be configured to accomplish retracting, lifting,compressing, supporting or repositioning tissue within the body of ahuman or animal subject. Moreover, the apparatus configured to deploythe anchor assembly as well as the anchor assembly itself are configuredto complement and cooperate with body anatomy. Further, the anchorassembly may be coated or imbedded with therapeutic or diagnosticsubstances, in particular Botulinum toxin, or such substances can beintroduced into or near an interventional site by the anchor deploymentdevice or other structure.

In another aspect, structure of the anchor assembly is designed toinvaginate within or complement tissue anatomy to thereby facilitatehealing and minimize infection risk or risk of calculus formation.Moreover, the anchor delivery device includes structure to form desiredangles between an extended position of the needle assembly relative tothe device. Additionally, it is contemplated that a distal end portionof the anchor delivery device be configured to facilitate the testing ofthe effectiveness of positioning of an anchor assembly. In this regard,the distal end portion is configured in a manner to allow the deviceoperator to mimic the effect a second anchor member will have prior toanchor delivery.

In one embodiment, the anchor delivery device includes a handle assemblywith a trigger attached thereto. The trigger is associated with a bodyof the handle assembly and is operatively attached to the needleassembly and structure that advances the first anchor member. Thetrigger is also operatively associated with structure that accomplishesassembling first and second parts of the second anchor member to eachother and to the connector member or by forming a single-piece secondanchor member around the connector member. Additionally, the handleassembly is equipped with structure that is configured in onecontemplated embodiment, to effect the cutting of the anchor assembly toa desired length and deployment of the structure at an interventionalsite.

In a specific embodiment, the anchor delivery device includes agenerally elongate tubular housing assembly member extending distallyfrom a handle assembly including a trigger. The proximal end of thehandle assembly is equipped with mounting structure configured toreceive a telescope or other endoscopic viewing instrument. A bore sizedto receive the telescope extends distally through a body of the handleassembly and continues through an outer tubular cover member forming thegenerally elongate member. Housed within the tubular housing assemblyare a telescope tube having an interior defining a distal section of thebore sized to receive the telescope, an upper tubular member assemblysized to receive a plurality of first components of the second anchormember and a needle housing configured to receive the needle assembly.Moreover, the generally elongate tubular housing includes a terminal endportion defined by a nose assembly which retains a plurality of secondcomponents of the second anchor members.

Additionally, in a preferred embodiment the first anchor member includesa tubular portion, a mid-section and a tail portion. The tail portion ofthe member further includes a connector section which acts as a spring.A terminal end portion of the tail is further contemplated to have asurface area larger than the connector section to provide a platform forengaging tissue.

Further, in the preferred embodiment, one component of the second anchormember is embodied in a pin having a first distal end equipped with apair of spaced arms and a second proximal end including groovesfacilitating pushability.

Moreover, various alternative methods of use are also contemplated. Thatis, in some applications of the invention, the invention may be used tofacilitate volitional or non-volitional flow of a body fluid through abody lumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, treat urinary incontinence, support or maintainpositioning of a tissue, organ or graft, perform a cosmetic lifting orrepositioning procedure, form anastomotic connections, and/or treatvarious other disorders where a natural or pathologic tissue or organ ispressing on or interfering with an adjacent anatomical structure. Also,the invention has a myriad of other potential surgical, therapeutic,cosmetic or reconstructive applications, such as where a tissue, organ,graft or other material requires retracting, lifting, repositioning,compression or support.

Other features and advantages of the present invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an elevation view, depicting a multi-actuating trigger anchordelivery system of the present invention;

FIG. 1B is an elevation view, depicting the system of FIG. 1A with thehandle case removed;

FIG. 1C is a rotated elevation view, depicting the system of FIG. 1Bwithout the handle case;

FIG. 1D is a detail view, depicting a distal end portion of the deviceof FIG. 1C;

FIG. 2A is a perspective view, depicting a core assembly of themulti-actuating trigger anchor delivery system of FIG. 1B;

FIG. 2B is a perspective view, depicting a shaft assembly of the coreassembly of FIG. 2A;

FIG. 2C is a perspective view, depicting another approach to formingsections of a shaft assembly;

FIG. 2D is a perspective view, depicting an alternate approach tostructure of a distal end portion of the system;

FIG. 2E is a perspective view, depicting a first step in forming analternative approach to a shaft assembly;

FIG. 2F is a perspective view, depicting a second step in forming analternative approach to a shaft assembly;

FIG. 2G is a perspective view, depicting a third step in forming analternative approach to a shaft assembly;

FIG. 2H is a perspective view, depicting a fourth step in forming analternative approach to a shaft assembly;

FIG. 2I is a perspective view, depicting a fifth step in forming analternative approach to a shaft assembly;

FIG. 3A is an elevation view, depicting a rocker arm assembly of themulti-actuating trigger anchor delivery system of FIG. 1B;

FIG. 3B is an elevation view, depicting the rocker arm assembly of FIG.3A with a crank spring assembly removed;

FIG. 3C is an elevation view, depicting the rocker arm assembly of FIG.3B with a large crank gear removed;

FIG. 3D is an elevation view, depicting the rocker arm assembly of FIG.3C with a rocker arm ratchet removed;

FIG. 3E is a rotated elevation view, depicting the rocker arm assemblyof FIG. 3D;

FIG. 3F is an isometric view, depicting the juxtaposition of the crankbearing assembly and the cam bearing assembly;

FIG. 4A is a rotated perspective view, depicting the spool assembly ofthe multi-actuating trigger anchor delivery system of FIG. 1B;

FIG. 4B is an exploded view, depicting the spool assembly of FIG. 4A;

FIG. 5A is an enlarged elevation view, depicting a trigger assembly ofthe multi-actuating trigger anchor delivery system of FIG. 1B;

FIG. 5B is an elevation view, depicting the trigger assembly of FIG. 5Awith a mounting block removed;

FIG. 5C is an elevation view, depicting the trigger assembly of FIG. 5Bwith a bell crank assembly removed;

FIG. 5D is a rotated perspective view, depicting the trigger assembly ofFIG. 5C with a mounting block cap removed;

FIG. 5E is an enlarged view, depicting the double pawl in a defaultposition;

FIG. 5F is an enlarged view, depicting the double pawl after triggerdepression;

FIG. 5G is an enlarged view, depicting the bell crank frame including abell crank follower;

FIG. 6A is an enlarged perspective view, depicting a reset assembly ofthe multi-actuating trigger anchor delivery system of FIG. 1C;

FIG. 6B is a perspective view, depicting the assembly of FIG. 6A with areset knob and reset one way wheel removed;

FIG. 7A is a perspective view, depicting one preferred embodiment of afirst anchor member of an anchor assembly of the present matter;

FIG. 7B is a side view, depicting the first anchor member of FIG. 7Aattached to a connecting member;

FIG. 7C is a perspective view, depicting components of one of thepreferred embodiments of the second anchor member in a configurationprior to assembly; and

FIG. 7D is a perspective view, depicting an assembled second anchormember of the present invention attached to a connecting member.

FIG. 8 is a cross-sectional view, depicting a first step of treating aprostate gland using the present invention;

FIG. 9A is a left side view, depicting the multi-actuating triggeranchor delivery system of FIG. 1A with the left handle half and resetassembly removed;

FIG. 9B is a left side view, depicting the assembly of FIG. 9A with thetrigger depressed;

FIG. 9C is a left side view, depicting the assembly of FIG. 9A with thetrigger partially returned and the rocker arm assembly removed;

FIG. 9D is a partial cross-sectional view, depicting the distal endportion of the anchor deployment device and the lateral advancement of aneedle assembly;

FIG. 9E is a cross-sectional view, depicting a second step of treating aprostate gland using the present invention;

FIG. 10A is a left side view, depicting the assembly of FIG. 9C with thetrigger being activated for a second time;

FIG. 10B is a left side view, depicting the assembly of FIG. 10A withthe trigger further depressed;

FIG. 10C is a left side view, depicting the assembly of FIG. 10B withthe trigger completely depressed;

FIG. 10D is a perspective view, depicting a distal end portion of theanchor deployment device of FIG. 9D after deployment of the firstanchor;

FIG. 10E is a cross-sectional view of the extendable tip, depicting theassembly of FIG. 10D;

FIG. 10F is a cross-sectional view, depicting a further step of a methodof treating a prostate gland using the present invention;

FIG. 11A is a left side view, depicting the assembly of FIG. 9A in aready position for a third actuation;

FIG. 11B is a left side view, depicting the assembly of FIG. 1A with thetrigger partially depressed;

FIG. 11C is a left side view, depicting the assembly of FIG. 11B withthe trigger completely depressed;

FIG. 11D is a perspective view, depicting the assembly of FIG. 9D afterthe complete retraction of the needle assembly;

FIG. 11E is a cross-sectional view, depicting yet another step of amethod of treating a prostate gland using the present invention;

FIG. 12A is a left side view, depicting the assembly of FIG. 9A in aready position for a fourth actuation;

FIG. 12B is a left side view, depicting an intermediate stage of thedepression of the trigger of the assembly of FIG. 12A;

FIG. 12C is a left side view, depicting the complete depression of thetrigger of the assembly of FIG. 12B with partial rotation of the cam;

FIG. 12D is a partial cross-sectional view, depicting the assembly ofFIG. 9D with the cover removed;

FIG. 12E is a partial cross-sectional view, depicting the deploymentdevice of FIG. 12D with a second component of the second anchor memberbeing advanced toward a first component of the second anchor member;

FIG. 12F is a left side view, depicting the assembly of FIG. 12C withfull rotation of the cam and the outer tube assembly pulled proximally;

FIG. 12G is a perspective view, depicting the assembly of FIG. 9D of thedelivery device with the second component completely advanced intolocking engagement with the first component and the connector membercut;

FIG. 12H is a cross-sectional view, depicting yet a further stepinvolved in treating a prostate gland using the present invention;

FIG. 13 is a left side view, depicting the multi-actuator trigger anchordelivery assembly of the present invention with the reset mechanismconfigured to recharge the system;

FIG. 14A is a cross-sectional view, depicting the implantation of anchorassemblies at an interventional site; and

FIG. 14B is an enlarged view, depicting one anchor component of theassemblies shown in FIG. 14A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present invention is embodied in a device configured todeliver anchor assemblies within a patient's body. As stated, thepresent invention can be employed for various medical purposes includingbut not limited to retracting, lifting, compressing, supporting orrepositioning tissues, organs, anatomical structures, grafts or othermaterial found within a patient's body. Such tissue manipulation isintended to facilitate the treatment of diseases or disorders. Moreover,the disclosed invention has applications in cosmetic or reconstructionpurposes or in areas relating the development or research of medicaltreatments.

In one particular aspect, the anchor assembly of the present inventionis contemplated to be formed of a structure which is visible byultrasound. Accordingly, the anchor assembly can be viewed duringultrasonic body scans such as during normal trans-rectal ultrasound whena medical professional is conducting diagnoses or treatment associatedwith conditions like prostate cancer.

In such applications, one portion of an anchor assembly is positionedand implanted against a first section of anatomy. A second portion ofthe anchor assembly is then positioned and implanted adjacent a secondsection of anatomy for the purpose of retracting, lifting, compressing,supporting or repositioning the second section of anatomy with respectto the first section of anatomy as well as for the purpose ofretracting, lifting, compressing, supporting or repositioning the firstsection of anatomy with respect to the second section of anatomy. It isalso to be recognized that both a first and second portion of the anchorassembly can be configured to accomplish the desired retracting,lifting, compressing, supporting or repositioning of anatomy due totension supplied thereto via a connector assembly affixed to the firstand second portions of the anchor assembly.

Referring now to FIGS. 1A-D, there is shown one embodiment of amulti-actuating trigger anchor delivery system 100 of the presentinvention. This device is configured to include structure that iscapable of both gaining access to an interventional site as well asassembling and implanting one or more anchor assemblies within apatient's body. In one aspect, the device 100 is configured to assembleand implant four anchor assemblies. The device is further contemplatedto be compatible for use with a 19 F sheath. The device additionallyincludes structure configured to receive a conventional remote viewingdevice (e.g., an endoscope) so that the steps being performed at theinterventional site can be observed.

The multi-actuating trigger anchor delivery device 100 includes a handleassembly 102 connected to an elongate tissue access assembly 104. Theelongate tissue access assembly 104 houses components employed toconstruct a plurality of anchor assemblies.

The anchor delivery system 100 further includes a number ofsubassemblies. A handle case assembly 106 including mating handle halveswhich encase the handle assembly 102. The handle assembly 102 is sizedand shaped to fit comfortably within an operator's hand and can beformed from conventional materials. Windows 107 can be formed in thehandle case assembly 106 to provide access to internal mechanism of thedevice so that a manual override is available to the operator in theevent the interventional procedure needs to be abandoned. A coreassembly 110 extends through the handle assembly 102, and includes thecomponents defining the elongate tissue access assembly 104.

The handle assembly 102 further includes a trigger system assembly 114,a spool assembly 116 and a rocker arm assembly 118. These assembliescooperate to accomplish gaining access to an interventional site as wellas the assembly and implantation of an anchor assembly at theinterventional site.

Moreover, a terminal end portion 119 of the anchor delivery systemincludes a distal tip assembly 128 shaped to provide an atraumaticsurface as well as one which facilitates desired positioning ofcomponents of an anchor assembly (See FIG. 1D). That is, by includingstructure that can mimic the ultimate position of a proximally orientedcomponent of an anchor assembly, an operator can test the effect of theanchor assembly prior to implantation. Once the operator confirms thatthe subject anchor component will be positioned as desired, theimplantation of the anchor is then undertaken and accomplished.

Turning now to FIGS. 2A-2B, there is shown a core assembly 110. Asstated, the core assembly 110 retains the components necessary toassembling a plurality of anchor assemblies. The core assembly 110includes a shaft assembly 120, a ratchet block assembly 122, an outercover block assembly 124, a stop assembly 126 and a distal tip assembly128. In one embodiment, the core assembly 110 is permanently attached tothe handle assembly 102. In an alternative embodiment, the core assemblyis temporarily attached to the handle assembly to allow for reuse of thehandle assembly and disposal of the core assembly.

With specific reference to FIG. 2B, the shaft assembly 120 furtherincludes an elongate endoscope tube 130 which extends from a scope rearmount 132 through a front plate assembly 134 and distally to a terminalend 136 of the shaft assembly 120. The endoscope tube accommodates aremovable endoscope. Additionally, extending distally from the frontplate assembly 134 and arranged generally parallel to the endoscope tube130 is a pusher tube assembly 138 including an anchor alignment tube formaintaining alignment of anchor components within the tube. Anotherelongate tubular housing 140 configured to receive a needle assemblyalso extends longitudinally from the front plate assembly 134. The frontplate assembly further includes a sheath sealing plate 143 which isconfigured to create a seal between and amongst the elongate componentsextending therethrough (See FIG. 2A).

In an alternate approach (See FIGS. 2C-D), it may be possible to havethe shaft assembly 120 constructed with mating extruded halves 146 tofunction equivalent to the current trilumen shaft assembly.

Further, the distal tip assembly 128 may be integral to one half of theelongate shaft. One or both of the halves 196 will have elongatechannels 147 that may be semi-circular or even square shared, but wouldfunctionally constrain and house both the telescope and needle assemblyin their unique channels. In a simple construction the second half maymerely close off the open channels 147 to constrain the telescope andneedle assembly.

The distal curved needle housing 148 that vectors the needle tip throughthe urethral wall (or other body lumen) is integral to one or both ofthe halves where if biased to one half the guiding surface may providemore intimacy and improved performance.

The pin storage tube 149 may be a Nitinol or stainless steel tube thatis either or both laser cut or laser welded with assembly features. Suchassembly features may be folded over tabs or points that may be capturedbetween the shaft extrusion assembly, thus integrating the parts tofunctionally act like the current invention at a lower complexity orcost.

In a yet further approach, an alternative construction of the shaftassembly 120 may incorporate a stamped metal element that is a singleelongate strip 151 of thin wall stainless steel (See FIGS. 2E-I).Fenetrations, castellations or tabs 153 (FIG. 2F) may be stamped aroundthe edges so as to be formed 155 (FIGS. 2G and H) to retain hypotubesadjacent to each other at distinct points that may later be insertmolded over or inserted into a simple plastic injected molded shell 159(FIG. 2I). The metal formed insert would provide more structuralstiffness and accuracy in assembly in contrast to singular plastic shaftassembly. Thus, the formed strip may appear as a wave pattern withintermittent tabs formed in the opposite direction of the locally formedstrip resulting in a plurality of concentric paths that hypotubes may beassembled through and fixed into position.

In one particular aspect, the core assembly 120 is further equipped withguide rails 145 which both lend structural support to the assembly aswell as guides along which various of the subassemblies are translatedwith the actuation of the trigger assembly. Also, the core assembly 120includes a longitudinally translatable outer tube assembly 142 (See FIG.2A), a distal end of which is received within the distal tip assembly128 (See also FIG. 1D). As described in more detail below the distal tipassembly houses a plurality of rings or cylinders and a spring biasedfeeder.

With reference to FIGS. 3A-E, the rocker arm assembly 118 of the handleassembly is described as is its interaction with the trigger systemassembly 114. The rocker arm assembly interacts with the multi-actuatingtrigger assembly to convert each single trigger pull into four differentactions of the anchor delivery system 100.

With particular reference now to FIGS. 3D and 3E, it is to beappreciated that the rocker arm assembly 118 is grounded at two points,at a rocker arm pivot point 173 and at a crank shaft 172. Both of theseelements are free to rotate, but not translate. A mid-section of theassembly 118 is characterized by a scotch yoke structure. As isconventionally known, the scotch yoke can be employed to convertrotational motion into linear motion. Here, the rocker arm assembly 118is powered by a spring assembly 162 and through interaction between thetrigger assembly 114 and a rocker pawl 163, this spring assembly 162 isselectively activated to effect rotation of a crank bearing assembly 176which is attached in an off-center position to a cam bearing assembly180. This in turn causes the cam bearing 180 to be guided along barriersdefined by an oval recess 178 formed in a lower rocker arm portion 152of the rocker arm assembly 118. Such action results in the rocker armassembly 118 to pivot at its lower end about the rocker pivot point 173and at its top end, linear motion results. This linear motion isemployed to selectively translate the spool assembly 116 longitudinally.

In one particular aspect, the rocker arm assembly 118 includes an upperrocker arm assembly 150, a lower rocker arm assembly 152 and upper 154and lower 156 break away links. A terminal end 157 of the upper rockerarm 150 is provided with a slot which slideably engages complementarystructure on the spool assembly 116, the interconnection of whichfacilitates the transition of articulating movement of the rocker armassembly into longitudinal motion of the spool assembly 116. Further, aspring (not shown) connects the upper rocker arm assembly 150 to theupper break away link 154. The damper assemblies 166 function as a modeof speed modulation which governs the action of the large gear 164 andthus the action of the rocker arm assembly 118 in response to thetrigger assembly 114. The damper assemblies 166 are filled with aselected amount of fluid having a known viscosity. The amount andviscosity of the fluid can be varied to achieve the desired dampeningeffect. In the approach contemplated, the lower rocker arm assembly 152includes a pair of spaced pivot points 158, 160 to which the upperrocker arm 150 and the lower break away link 156 are pivotablyconnected. Further, a pivoting connection exists between the upper 154and lower 156 break away links. The rocker arm assembly further includesa crank spring assembly 162 mounted on the lower rocker arm assembly152.

With the crank spring assembly 162 removed (See FIG. 3B), the engagementbetween a large gear 164 and a pair of spaced damper assemblies 166 canbe better appreciated. Configured on the same side of the lower rockerarm assembly 152 and adjacent to the large gear 164 is a rocker armratchet 168 (See FIG. 3C). A crank arbor 170 is positioned on an outsidesurface of the rocker arm ratchet 168. It is to be recognized that as aresult of the actuation of the trigger assembly the crank springassembly 162 drives the crank 170 counter clockwise and thereby movesthe rocker arm assembly 118 forward and backwards about rocker arm pivotpoint 173.

Each of the rocker arm ratchet 168 and crank arbor 170 (See FIG. 3C) areconfigured upon a centrally configured crank shaft 172, the crank shaftpassing through a curved slot 174 formed in the lower rocker arm 152(See FIG. 3D). On the opposite side of the lower rocker arm assembly 52and also mounted on the crank shaft 172 is an eccentrically arrangedcrank bearing assembly 176 (See FIG. 3E). See also FIG. 3F which depictsthe juxtapositioning of the crank bearing assembly 176 and the cambearing assembly 180.

Moreover, as stated, configured on a portion of the crank bearing 176and within an oval recess 178 formed in the lower rocker arm 152 is acam bearing 180. The crank bearing 176 is rotationally coupled to thecrank shaft 172 and thereby converts the rotational motion to linearmotion at the terminal end 157 of the upper rocker arm 150 as in ascotch yoke. Additionally, in operation the crank spring assembly 162 iskept from unloading by a spring-loaded, rocker pawl 163 (See FIG. 3C),the rocker pawl being tripped during certain stages of triggeractivations. In this regard, the assembly is equipped with a no-skipfeature. That is, as best seen in FIG. 3C, the rocker arm ratchet 168 isequipped with a no-skip cam surface 175. As the trigger assembly causesone end of the rocker pawl 163 to disengage from the rocker arm ratchet168 and the rocker arm ratchet 168 rotates in response to the energyprovided by the crank spring assembly, a no skip link cam follower 177engages the no skip cam surface 175. This action results in properlypositioning the components to prevent pawl skipping and double needledeployment due to high crank speed and low reaction speed of the pawl163 after tripping. A torsion spring 179 is provided at the verticallypositioned pivot point 158 to prevent high speeds in the lower rockerarm 152 to help control the speed of rotation of the rocker arm ratchet168. As can be seen in the FIGS., the rocker arm ratchet 168 includesonly two teeth which are alternatively engaged by the rocker arm pawlassembly 163. These teeth are spaced such that an advance stroke occurson one pawl trip and a retract stroke occurs on the next pawl trip.

Additionally, during the stage of activation of the trigger assemblywhen the terminal end 159 hits the stop assembly 126 and there isrotation of the lower rocker arm assembly 152, the upper 154 and lower156 break away links break in that the pivot joint between the twomembers translates inwardly toward the upper rocker arm assembly 150.This breakaway action allows the lower rocker arm 152 to continuethrough an entire stroke while the upper breakaway link rocker arm 154rotates in an opposite direction such that no further translation isimparted upon the terminal end 157, the spool assembly 116 and theneedle assembly connected thereto stop at a depth set by the stopassembly 126. Accordingly, this mechanism controls the movement of thespool assembly as more fully described below.

Finally, the windows 107 formed in the handle 106 can be used to alsoaccess portions of the rocker assembly 118 or the handle housing 106itself can be removed to do so. Thus, the crank bearing assembly 176 canbe manually turned to accomplish desired movement of components turningthe rocker arm assembly. A bailout feature is thus provided to, forexample, retract the needle assembly.

Turning now to FIGS. 4A and 4B, there is shown a spool assembly 190. Thespool assembly is used to push anchor components from the distal end ofthe anchor delivery device. The rotary mechanism is particularlyadvantageous in that it allows several anchor assemblies (e.g. four)with approximately 6 cm (corresponds to ½ of circumference of spool) ofconnector material such as monofilament PET, 0.015 inch diameter betweenanchors to be stored in a relatively small device that fits in a user'shand. The spool assembly 190 further includes a tension housing assembly192, a deploy housing assembly 194, and a damper assembly 196.

The tension housing assembly 192 is configured between a housing cap 198and the deploy housing assembly 194. The spool assembly 190 furtherincludes a circular recess 200 in the tension housing 201 that is sizedand shaped to receive a tension arbor with tension spring. In oneapproach, the tension spring applies one pound of tension to an implantcomponent once the component has been deployed, but less and moretension can be provided as desired. Further, the assembly is configuredso that no tension is applied prior to implantation. Also, the tensionspring 204 is loaded up to ½ turn as the needle is retracted, therebytensioning the suture, and then it unloads, thereby retracting thecapsular anchor assembly after the urethral anchor is delivered and thesuture is cut. The housing cap 198 retains the tension arbor 202 andtension spring 204 within the circular recess 200. Moreover, the spoolhousing 190 may further include bushings 206 which fit within holes 208formed through a pair of spaced arms 209 extending from a top of thetension housing assembly 192. The bushings 206 provide a surface forsmooth movement along rails 140 of the core assembly 110 (See FIG. 2A).

As shown in FIG. 4B, the deploy housing assembly 194 is configured witha first circular recess 208 facing the tension housing assembly 192. Thefirst recess 208 is sized and shaped to receive a spool assembly with acentral shaft 230. The adjacently arranged tension housing assembly 192retains the spool assembly 210 within the first recess 208. It is to berecognized that a wire (not shown) is wound around the spool assembly210. This wire is bonded to an implant (anchor) assembly and transmitsthe driving force and tensioning torque from the spool assembly 190 tothe implant components during the deployment of an anchor assembly. Asecond recess (not shown) is formed in an opposite side of the deployhousing assembly 194 which faces the damper assembly 196. This secondcircular recess is sized and shaped to receive a spool ratchet disc 214sandwiched between a deployment arbor with central shaft 216 and asuture deploy spring 218 which is initially fully loaded with enoughenergy to drive four distal anchor members out of the needle. The damperassembly 196 retains the spool ratchet disc 214, deployment arbor 216and suture deploy spring 218 within the second recess of the deployhousing assembly 194. The deploy housing assembly 190 is furtherequipped with a spring loaded suture deploy pawl assembly 219 receivedwithin a recess formed in a bottom lateral surface of the housing 194.It is to be noted that the spool ratchet disc 214 is coupled to thedeployment arbor 216 in a manner such that the deployment spring (notshown) is refrained from unloading until the deploy pawl 219 is tripped.The no-skip mechanism again here prevents double deployments if theprimary mechanism moves faster than the pawl's 219 response times.

The damper assembly 196 includes a damper body 224 and a damper rotor220 which have multiple interleaved circular surfaces such that thedamper rotor 220 can rotate within the damper body 224. The gaps betweenthe interleaved surfaces are filled with viscous dampening fluid (notshown). The damper rotor 220 has a square peg which positively andpermanently engages into the square port of the deploy arbor 216,thereby providing speed modulation to the deploy spring 218 as it isunloaded to deploy the distal anchor member out of the needle.

A central shaft 230 is configured through the tension housing assembly192 and extends to within the deploy housing assembly 194. A squaresection 231 of the shaft 230 is always engaged in the spool assembly 190with either the deployment arbor 216 or the tension arbor 202. Thus,when the deployment pawl 219 is released, the square section of thecentral shaft 230 is engaged with the deployment arbor 216 and isdisengaged from the tension arbor 202. This allows the deployment springto drive the spool 210 180 degrees. A throwout arm assembly 232 isretained on the central shaft 230 and includes a forked substructure 234configured to engage complementing structure of the trigger assembly114. The throwout arm assembly is activated by the trigger assembly totranslate the shaft 230 between the deployment arbor 216 and the tensionarbor 202 at desired time points in the delivery process.

The window 107 formed in the handle case assembly 106 (See FIG. 1A) canbe configured to provide convenient direct access to components of thespool assembly 190 in the event any of the components become stuck. Forexample, force can be directly applied to the throwout arm 232 so thatthe shuttle action of the assembly can be facilitated.

With reference now to FIGS. 5A-E, the components of the trigger systemassembly 114 are described. The trigger assembly 114 includes a triggerrack assembly 240, a trigger cam assembly 242, a lower cam assembly 244and a bell crank assembly 246, each of which are attached or separatelyassociated with a mounting block assembly 248. A pawl assembly 249 isfurther provided to alternatively engage the lower cam assembly. A pindrive rear link 250 is also provided and which is pivotably attached tothe lower cam assembly 244. For ease of understanding of the relativepositioning of the various components, the mounting block assembly 248has been removed from the structure depicted in FIGS. 5B and 5C and thebell crank assembly 246 has been removed from FIG. 5C.

The trigger rack assembly 240 includes a mechanical rack 252 extendingfrom a trigger 254 sized and shaped to receive a portion of anoperator's hand. Also extending from the trigger 254 is a phasing dowel256 which is configured to limit the depression of the trigger 254. Thetrigger rack assembly 240 further includes a spring 258 for biasing theassembly away from the mounting block assembly 248.

The rack 252 of the trigger rack assembly 240 engages the trigger camassembly 242. The trigger cam assembly 242 further includes a triggerpinion 259 (See FIG. 5D) with teeth which mate with the teeth of therack 252. The trigger pinion 259 is placed adjacent to a cam subassembly260, each of which are positioned on a central trigger shaft 262.

The lower cam assembly 244 includes a link 264, one end of which travelsthrough an open V-shaped slot formed in the lower cam plate 266. Alsoformed in the lower cam plate 266 is a through hole 267 for receiving ashaft of a reset assembly (described below in connection with FIGS. 6Aand 6B). The opposite end of the link 264 is configured to slide withina slot 269 formed within the pin drive rear link 250. A top end 268 ofthe pin drive rear link 250 is operatively associated with structure foradvancing components of the anchor assembly through the core assembly120.

The bell crank assembly 246 includes a T-shaped frame 270 at the top ofwhich are a pair of spaced arms 272 (FIG. 5A). Configured between thearms is a bell crank rail 274. On a back side of the structure isconfigured a bell crank follower 275 (See FIG. 5G).

As best seen in FIG. 5D where the mounting block cover 276 is removed,the trigger assembly 114 further includes a deploy plate assembly 280.This assembly includes a deployment plate 282 to which are pivotablyattached a first link 284 and a second link 286. A double pawl assembly288 is further provided, the operation of which is controlled by a spragactuator 290 which is mounted to the trigger rack 242.

The double pawl assembly 288 is configured to act as a trigger controlmechanism. In a first default position, the double pawl assembly 288engages the rack assembly 240 in a manner which permits the trigger 254to be depressed while allowing for and holding partial depression andpreventing incomplete depression (See FIG. 5E). Once the trigger 254 iscompletely depressed, the sprag actuator 290 engages the double pawlassembly causing it to rotate such that the default engagement betweenthe rack assembly 240 and the double pawl assembly 288 is eliminated(See FIG. 5F). Thereafter, the rack assembly 240 can return via the biasspring 258 to its original position (See FIG. 5D). As the defaultengagement of the rack assembly 240 and double pawl assembly 288 iseliminated, a second alternative engagement is created. In the secondengagement, the double pawl assembly permits the trigger 254 and rackassembly 240 to return to the original position and prevents anincomplete return to the original position. That is, the double pawlassembly controls the trigger stroke bi-directionally. Thus, theengagement between the double pawl assembly 288 and the sprag actuator290 then limits the degree to which the trigger can be depressed as wellas facilitates the return of the trigger 254 to its default orun-depressed position.

Accordingly, the single trigger 254 actuates all steps of deploymentthrough operative association with the rocker pawl assembly 163 and thethrowout arm assembly 232. That is, activation of the trigger 254 causesthe bell crank assembly 270 to pivot laterally taking with it thethrowout arm assembly 232. By way of its connection to the central shaft230, the throwout arm accomplishes the shuttling of the shaft 230between functions performed by the spool assembly 190. Moreover,actuation of the trigger 254 further accomplishes the alternativeengagement and disengagement between the rocker pawl 163 and the crankarbor 170. This engagement and disengagement permits the longitudinalmovement of the spool assembly 190 between rear and forward positions.As a needle assembly and pusher assemblies are operatively linked tothis mount, this longitudinal movement is likewise controlled by thetrigger 254 actuation.

Further trigger control is provided by the interaction between thephasing dowel 256 and the trigger cam subassembly 260. That is, thetrigger cam 260 includes a plurality of slots 291 formed in a peripherythereof. These slots 291 receive a terminal end of the phasing dowel 256so that continued rotation of the trigger cam 260 in response to triggerdepression is inhibited by the engagement between these parts. A rollerclutch (not shown) configured within the trigger cam 260 provides yetfurther control by inhibiting the cam 260 from moving except during aninward trigger stroke.

The window 107 in the handle case 106 (FIG. 1A) can further beconfigured to provide access to components of the trigger assembly 114.That is, the double pawl assembly 388 can be manually engaged, forexample, to thereby override a jam. Likewise, other components of theassembly 114 can be so engaged to facilitate proper function.

The handle assembly 102 further includes a reset assembly 300 (See FIGS.1C and 6A-B) for resetting the delivery system after deploying andimplanting an anchor assembly to be ready to deploy another anchorassembly. The reset assembly 300 includes a reset knob 302 rotatablymounted to a reset plate 303 and having an interior configured toreceive an engagement spring 304. A lever 305 is further provided foreasy manipulation of the assembly. Also, a pair of bearings 306, 308 areprovided to mate with the reset knob 302 and to provide a surface forengaging a shaft 309 extending laterally through hole 267 of the triggerassembly 114. A knob latch 310 is configured to releasably engage theknob 302.

The reset assembly 300 also includes a one way reset wheel assembly 312mounted to the reset plate 303 to which a reset link 314 is rotatablyconnected. The reset wheel assembly 312 prevents backwards motion of theshaft until the reset action is complete. The reset action recharges thespring 304 which powers the urethral cam 244 (FIG. 5D). Near an oppositeterminal end of the reset link 314 is a threaded projector 316 adaptedto engage complementary structure of the knob 302 (See FIG. 6B). Thereset assembly 300 also includes a one way reset clutch 320 configuredconcentrically within a reset bearing 322. Also contained within thereset assembly is a U-shaped reset wire form 324. Bumpers 326 areprovided to deflect the U-shaped wire form 324 which acts on the bumpers326 to push the one way reset wheel 312 out of the top dead center andbottom dead center positions where the link 314 cannot rotate the wheel312.

In the above description springs have been described as the mechanismfor actuating the various assemblies when the trigger is pulled,however, it is also within the scope of the invention to use othermechanisms such as motor, compressed gas, elastomers and the like.

One preferred embodiment of an anchor assembly of the present inventionis depicted in FIGS. 7A-D. In its unconstrained configuration, the firstor distal anchor component 370 includes a first tubular portion 372which is generally orthogonal to a second tail portion 374. It is to benoted, however, that while housed in a delivery assembly and prior todeployment at a target area, the first anchor component 370 isconstrained to define a generally straight configuration, onlysubsequently assuming the unconstrained configuration upon deploymentfrom the delivery device.

The tubular portion 372 of the first anchor component 370 includes aplurality of tabs 376 which can be deformed or deflected to accomplishaffixing the component 370 to a connector assembly 378 (See FIG. 7B). Ithas been found that three such tabs 376, two on one side of the tubularportion 372 and one on an opposite side provide a sufficient connectingforce and a desired balance between the connector 378 and first anchorcomponent 370 and to move the first anchor component 370 by applying aforce either in the proximal or distal direction.

It is contemplated that the first anchor component 370 can be laser cutfrom a tube formed of nitinol or other appropriate material. Amid-section 380 of the component 370 provides a structural transitionfrom the tubular portion 372 to the tail portion 374. As such, a portionof a side wall is removed in the mid-section area 380. A further portionof the side wall is removed to define a connecting section 382 of thetail 374 which extends from the mid-section 380. This connector section382 acts as a spring to accomplish the relative unconstrained angleassumed between the tail 374 and tubular portion 372. A terminal endportion 383 of the tail 374 embodies structure having a surface areawhich is larger than that of the connector section 382 to therebyprovide a substantial platform for engaging tissue at a target site.

As shown in FIGS. 7C and D, the second anchor component 384 includes afirst part 386 and a second part 388. Once the first anchor component370 is positioned at a target site by employing a delivery device suchas that disclosed below (or previously), the second anchor component 384is assembled in situ.

The first part 386 of the second anchor component 384 includes aninternal bore 390 sized to receive a portion of the second part 388 ofthe second anchor component 384 in a locking engagement. An externalsurface of the first part 386 is sized and shaped to include a proximalcollar 391 spaced from a mid-section 392, each of which have generallycylindrical profiles. A smaller diameter, outer cylindrical portion 393is configured between the proximal collar 391 and mid-section 392 of thecomponent and a distal cylindrical portion 394 having yet a smallercylindrical profile defines a distal end thereof.

The second part 388 of the second anchor component 384 includes a solidgenerally cylindrical back end 395, extending from which are a pair ofspaced prongs 396. Terminal ends of the prongs 396 can be tapered toboth facilitate the insertion of the prongs 396 within the internal bore390 of the first part 386 as well as to receive a section of theconnector assembly 378. Notably, the prong structure commences at anarrowed slot 397 which steps outwardly to a wider dimension to therebydefine the space between the prongs 396. This narrow slot 397 providesthe second part 388 with desired structural rigidity to receive theconnector assembly 378 and to facilitate lockingly engaging theconnection between the first 386 and second 388 parts. The space betweenthe prongs 396, in one embodiment can be dimensional relative to thediameter of the connector 378 such that is has sufficient clamping forcesuch that the first part 386 is not needed and therefore is optional forproviding additional security.

Thus, in its pre-implanted form, the anchor assembly can include oneanchor member (e.g., first anchor) whose initial engagement with aconnector is generally coaxial and another anchor member (e.g., secondanchor) with an initial engagement being generally perpendicular withthe connector.

These assemblies can further be employed to deliver therapeutic ordiagnostic substances to the interventional site. For example, in aprocedure to treat a prostate gland, substances that cause the prostateto decrease in size such as 5-alpha-reductase inhibitors can beintroduced at the treatment site. A particular advantageous procedure isto use the needle of the anchor delivery device to inject 100 to 200units of botulinum toxin (such as available from Allergan, Inc.)dissolved in 4 mL of saline either before, during or after deploying theanchor assembly. Preferably, 2 mL are injected in each lobe of theprostate. Another advantageous procedure is to use the needle of theanchor delivery device to inject 100 to 300 units of botulinum toxindissolved in 10 to 30 mL of saline into the base of the bladder, bladderlateral walls and/or trigone. Preferably, 0.5 to 1.0 mL are injectedinto about 20 to 30 sites in the bladder for treating over-activebladder. Other substances but not limited thereto, which may beintroduced at the site include various scarring agents, rapamycin andits analogues and derivatives, paclitaxel and its analogues andderivatives, phytochemicals, alpha-1a-adrenergic receptor blockingagents, smooth muscle relaxants and other agents that inhibit theconversion of testosterone to dihydrotestosterone.

In a first step to deliver and deploy an anchor assembly for the purposeof manipulating tissue or other anatomical structures, the endoscopedevice is employed to view the positioning of a multi-actuating triggeranchor delivery device 100 at the interventional site, for example, theelongate tissue access assembly 104 of the device is inserted into thepenis of a patient and advanced until the distal end 128 is adjacent aninterventional site in the urethra (UT) adjacent the bladder (UB; SeeFIG. 8). It has been found that a mechanical solution to the treatmentof BPH such as that of the present invention, can be more compatiblewith patients recovering from prostate cancer compared to energy-basedsolutions. Furthermore, the present invention also contemplates stepsfor sizing the anatomy. As it relates to BPH treatment, the presentinvention also involves the placement of an ultrasonic or other devicein the patient's body, such as in the rectum, to measure the necessarydepth of insertion of the distal end of the needle assembly within thepatient's body. This information can be used to set or create a depthstop for the needle assembly by the operator using a knob (not shown) onthe outside of the handle connected to the stop assembly 126 so thatduring deployment the distal end of the needle assembly extends all theway through the prostate from inside the urethra to outside of theprostate capsule.

After so positioning the deployment device within the patient, themulti-actuating trigger anchor delivery device 100 is employed toassemble and implant an anchor assembly at an interventional site. In afirst step, the trigger 254 of the trigger assembly 114 is depresseduntil through its inter-connection with the rocker arm assembly 118 viathe trigger cam subassembly 260, the rocker pawl follower 163 isreleased from a locking engagement with the rocker arm ratchet 168 (SeeFIG. 9A). Releasing the rocker arm ratchet 168 results in the unloadingof the crank spring assembly 162 thereby causing rotation of theeccentric crank 176 and thereby the rocker arm assembly 118 and theforward translation of the upper portion of the rocker arm assembly 118and the spool assembly 116 (See FIG. 9B). This is permitted through theinteraction of the upper rocker arm assembly 150, the lower rocker armassembly 152, and upper 154 and lower 156 break away links and a depthstop assembly 410 (See also FIGS. 2A and 3A). That is, the depth stopassembly 410 engages the upper break away link 154 so that it breaks (orrotates) with respect to the lower link 156 to limit the forward motionof the spool assembly. Such action accomplishes the advancement of aneedle assembly 400 within the elongate tubular housing 140 via itsconnection with the spool assembly 116 (See FIG. 9D). Moreover, thedepth stop assembly 410 can be positioned as desired to control thedepth to which the needle assembly 400 is projected. The selectedposition may be based on anatomical measurements made by various imagingtechniques such as ultrasound.

Release of the trigger 254 permits the trigger 114 to return to a readyposition, leaving the spool assembly 116 in its forward position (SeeFIG. 9C). The articulation of the double pawl assembly 288 from itsdefault position (See also FIG. 5D) facilitates this return of thetrigger assembly 114 to the ready position. Within the patient'sanatomy, the advancement of the needle assembly 400 consequently resultsin the needle passing through the prostate gland (PG) (See FIG. 9E). Inone contemplated approach, a terminal end of the needle 400 ispositioned to extend beyond the prostate gland (PG) but it is to berecognized that the degree of needle insertion can be modified for aparticular purpose.

Next, the trigger assembly 114 is employed again to effect thedeployment of the distal anchor component 370 (See FIGS. 10A-F). Withthe spool assembly housing 116 in a forward position, a first half of atrigger 254 pull (FIG. 10A) causes the spool shaft 230 to move to thedeploy side 194 of the spool assembly 190 (FIGS. 10A and 4A-B). This isaccomplished via cooperation with the bell crank assembly 246 (See alsoFIG. 5A) which drives the throw out arm assembly 232 (See also FIGS.4A-B). More specifically, with the depression of the trigger 254, thetrigger cam 260 rotates. The bell crank follower 275 (See FIG. 5G)connected to the bell crank frame 270 rides along a variable surfaceformed on a side of the rotating trigger cam 260, the variability of thesurface causing the bell crank frame 270 to pivot away from the spoolassembly housing 116 at a desired juncture. This causes the bell crankframe 270 to pivot the throw out arm assembly 232 which in turn advancesthe spool shaft 230 to the deploy side of the spool assembly 190.

As the trigger 254 is continued to be depressed (FIG. 10B), the deployplate 280 of the trigger assembly 114 (See also FIG. 5D) is positionedin a raised configuration. This raised position results from thevertical movement of a deploy plate push rod (not shown) which at oneend rides along a periphery of the trigger cam 260 and at another endengages the deploy plate 280. As the push rod engages upon raisedsections of the periphery of the trigger cam 260, the rod is translatedvertically which causes the deploy plate 280 to rise. Being sopositioned, the deploy plate assembly 280 actuates the suture deploypawl assembly 219 (See also FIGS. 4A-B), which in turn, permits therelease of the deploy spring 218 and coupled rotation, via the spoolshaft 230, of the deploy spring 218 and the spool assembly 210 therebyadvancing the suture from the delivery system 100. The two-toothed spooldeploy ratchet 214 permits one half-turn of the spool assembly 210before reengaging with the suture deploy pawl assembly 219 and arrestingthe suture advancement. At the finish of this second trigger 254 pullthe deploy plate assembly 280 and the deploy pawl assembly 219 are backin their default positions (FIG. 10C).

At the distal end 128 of the multi-actuating trigger anchor deliverysystem 100, such action facilitates the advancement of the first ordistal anchor component 370 attached to the connector 378 out of theneedle assembly 400 (See FIG. 10D). As shown in FIG. 10E, a wireassembly 402 engages the connector 378 through a permanent connectionsuch as a polyimide tube with adhesive. By way of its interconnectionwith the spool assembly 210 of the tension housing assembly 192 (Seealso FIGS. 4A-B), the desired length of the connector 378 is paid out.It is to be recognized that the wire assembly 402 has been shown in FIG.10E for demonstrative purposes as its actual position may be furtherwithin the needle assembly 400 at this stage of device use. A connectordiameter of approximately 40% of the inside diameter of the needleassembly 400 or greater is beneficial to pay out the connector 378 toprevent kinking of the connector material. The connector is preferablyabout 0.015 inch diameter PET monofilament. Moreover, at this stage notension is supplied to the connector 378 and first anchor component 370by the tension housing assembly 192.

Accordingly, as shown in FIG. 10F, the first anchor component 370 isejected from the needle housing beyond an outer surface of a prostategland (PG). Of course, when desirable, the first anchor component 370can surgically be placed within the prostate gland (PG) or in otherprocedures at any position within a patient.

Referring now to FIGS. 11A-E, the multi-actuating trigger anchordelivery system 100 is manipulated to withdraw the needle assembly 400from the interventional site. As shown in FIG. 11A after the firstanchor component is ejected from the needle assembly 400, the trigger254 is again returned to a ready position. With the commencement of thethird trigger 254 pull (FIG. 11B), the central shaft 230 is shuttledback to the tension side 192 of the spool assembly 116 (See also FIGS.4A-B). Again, it is the cooperation of the bell crank assembly 246 andthe throw out arm assembly 232 that facilitates the shuttling of thecentral shaft 230. Further depression of the trigger 254 results in thespool assembly 116 and rocker arm assembly 118 returning to a defaultposition, again by lifting the rocker pawl 163 and releasing the crankspring assembly 162. Consequently, the needle assembly (not shown) whichis attached to the spool assembly 116, is withdrawn completely withinthe needle tubular housing 140 (See FIG. 11D). Thus, the first anchorcomponent 370 is left at the intervention site with the connectorassembly 378 extending proximally within the elongate tissue accessassembly 104 (FIG. 11E). During this juncture, a desired tension isplaced upon the connector 378 and first anchor component 370 by tensionhousing assembly 192 of the spool assembly housing 116. Moreover, thetension assembly 192 permits additional suture to be paid out relativeto the retracting spool assembly 116. It is this combination of suturepay-out and the function of the tension spring which facilitates thedelivery of a custom-length, fixed-load implant.

Again with the trigger 254 automatically returning to a ready position(See FIG. 12A), the next step of the implant procedure can beaccomplished. That is, as the trigger 254 is depressed for the fourthtime (FIG. 12B), the pawl assembly 249 of the trigger assembly 114 isreleased from a locking engagement with the lower cam assembly 244 ofthe trigger assembly 114 (See also FIG. 5A). The complete depression ofthe trigger 254 (FIG. 12C) then effects the horizontal driving of theshaft 264 by the lower cam plate 266 of the lower cam assembly 244 (Seealso FIG. 5C). Consequently, the pin drive rear link 250 is translatedforwardly and through its connection to the ratchet block assembly 122(see also FIG. 2A), a pusher assembly (not shown) placed in appositionwith rear-most second part 388 of the second anchor component is alsoadvanced forwardly.

Irrespective of the specific form of the anchor assembly, a next step inthe context of prostate treatment involves positioning the proximalanchor assembly, for example, within a desired section of the urethra ofthe patient. Prior to doing so, the patient can be monitored todetermine whether there has been any evidence of improvement through theplacement of the anchor. One such symptom is whether there has been anyurination. After so checking, the proximal anchor assembly can beimplanted.

Therefore, as shown in FIGS. 12D and 12E, by way of the pusher assembly,a second part 388 of the second anchor component is advanced intoengagement with the connector 378 of the anchor assembly. The secondpart 388 is then further advanced into engagement with the first part386 of the second anchor (FIG. 12G). At this juncture, the outer tubeassembly (not shown) is pulled proximally to cut the connector 378 (SeeFIG. 12G) and release the assembled second anchor assembly from thedistal end 128 of the multi-actuator trigger anchor delivery system 100.The proximal motion of the outer tube assembly is accomplished throughthe cooperation of an outer tube link 420 and the lower cam assembly244. That is, as the lower cam assembly 244 rotates forwardly, itscamming surface engages and rotates the outer tube link 420 in anopposite direction. By way of its connection to the outer tube assembly,the outer tube link 420 drives the outer tube assembly rearwardly.

As shown in FIG. 12H, the assembled anchor assembly is placed across theprostate gland (PG) with the first anchor component 370 configuredagainst an outer surface of the prostate gland (PG) and the secondanchor component 384 implanted with the urethra (UT). Again, it is to berecognized that the anchor assembly can be placed in other orientationsthroughout a patient's anatomy.

Finally, the lever 305 of the reset assembly 300 is actuated to resetthe system for assembling and implanting another second anchor component384. That is, the lever 300 is pulled back to recharge the spring 304 ofthe reset assembly 300 to thereby return all of the assemblies to thecorrect position for accomplishing the assembly and release of thesecond anchor component 384. Moreover, it is to be recognized that thesteps and mechanisms involved in delivering other components of theanchor assembly are effected with pre-loaded energy so that a desirednumber (e.g. four) of such components can be implanted.

Accordingly, the present invention contemplates both pushing directly onanchor portions of an anchor assembly as well as pushing directly uponthe connector of the anchor assembly. Moreover, as presented above, thedistal or first anchor component is advanced and deployed through aneedle assembly and at least one component of the proximal or secondanchor component is advanced and deployed through a generally tubularportion of the anchor deployment device. Further, both a single anchorassembly or multiple anchor assemblies can be delivered and deployed atan intervention site by the deployment device. Consequently, in thecontext of prostate treatment, the present invention accomplishes boththe compression of the prostate gland and the opening of the prostaticurethra, the delivering of an implant at the interventional site, andapplying tension between ends of the implant. Moreover, drug delivery isboth contemplated and described as a further remedy in BPH and overactive bladder treatment.

Once implanted, the anchor assembly (See FIGS. 14A and 14B) of thepresent invention accomplishes desired tissue manipulation, compressionor retraction as well as cooperates with the target anatomy to providean atraumatic support structure. In particular, the shape and contour ofthe anchor assembly 500 can be configured so that the assemblyinvaginates within target tissue, such as within natural folds formed inthe urethra by the opening of the urethra lumen by the anchor assembly.In fact, in situations where the anchor assembly is properly placed,wispy or pillowy tissue in the area collapses around the anchorstructure. Eventually, the natural tissue can grow over the anchorassembly 500 and new cell growth occurs over time. Such cooperation withtarget tissue facilitates healing and avoids unwanted side effects suchas calcification or infection at the interventional site.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the present invention also contemplates approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

It has been observed that placing the anchors at various desiredpositions within anatomy can extract the best results. For example, whentreating a prostate, one portion of an anchor can be placed within anurethra. It has been found that configuring such anchors so that teno'clock and two o'clock positions (when looking along the axis of theurethra) are supported or retained, effectively holds the anatomy openand also can facilitate invagination of the anchor portion withinnatural tissue. This is particularly true in the regions of anatomy nearthe bladder and the juncture at which the ejaculatory duct connects tothe urethra.

Additionally, it is contemplated that all components of the anchorassembly or selected portions thereof (of any of the anchor assembliesdescribed or contemplated), may be coated or embedded with therapeuticor diagnostic substances (e.g. drugs or therapeutic agents). Again, inthe context of treating a prostate gland, the anchor assembly can becoated or imbedded with substances such as 5-alpha-reductase which causethe prostate to decrease in size. Other substances contemplated includebut are not limited to phytochemicals generally, alpha-1a-adrenergicreceptor blocking agents, smooth muscle relaxants, and agents thatinhibit the conversion of testosterone to dihydrotestosterone. In oneparticular approach, the connector 95 can for example, be coated with apolymer matrix or gel coating which retains the therapeutic ordiagnostic substance and facilitates accomplishing the timed releasethereof. Additionally, it is contemplated that bacteriostatic coatingscan be applied to various portions of the anchor assemblies describedherein. Such coatings can have various thicknesses or a specificthickness such that it along with the connector itself matches theprofile of a cylindrical portion of an anchor member affixed to theconnector. Moreover, the co-delivery of a therapeutic or diagnostic gelor other substances through the implant deployment device or anothermedical device (i.e. catheter), and moreover an anchor assemblyincluding the same, is contemplated. In one such approach, thedeployment device includes a reservoir holding the gel substance andthrough which an anchor device can be advance to pick up a desiredquantity of therapeutic or diagnostic gel substance.

It is to be recognized that the timing of the dual advancement of theneedle and connector assemblies and subsequent relative motion betweenthe assemblies is coordinated. That is, the needle assembly firstprovides access to an interventional site and then the connectorassembly is extended beyond a terminal end of the needle assemblythrough the relative motion of the needle and connector assemblies.

It is further contemplated that in certain embodiments, the anchordelivery device can include the ability to detect forces being appliedthereby or other environmental conditions. Various sections of thedevice can include such devices and in one contemplated approach sensorscan be placed along the needle assembly. In this way, an operator candetect for example, whether the needle has breached the targetanatomical structure at the interventional site and the extent to whichsuch breaching has occurred. Other sensors which can detect particularenvironmental features can also be employed such as blood or otherchemical or constituent sensors. Moreover, one or more pressure sensorsor sensors providing feedback on the state of deployment of the anchorassembly during delivery or after implantation are contemplated. Forexample, tension or depth feedback can be monitored by these sensors.Further, such sensors can be incorporated into the anchor assemblyitself, other structure of the deployment device or in the anatomy.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can simply cut the connectorand simultaneously remove the second anchor previously implanted forexample, in the patient's urethra.

An aspect that the various embodiments of the present invention provideis the ability to deliver multiple, preferably four, anchor assemblieshaving a customizable length and distal anchor components, each anchorassembly being implanted at a different location without having toremove the device from the patient. The various embodiments provide forvariable needle depth and variable connector length for each of themultiple anchor assemblies delivered. Other aspects of the variousembodiments of the present invention are load-based delivery, preferably1 pound, of an anchor assembly, anchor assembly delivery with a devicehaving integrated connector, (e.g. suture), cutting, and anchor assemblydelivery with an endoscope in the device. The delivery device isuniquely configured to place such a load (half pound to five pounds)between spaced first anchor members as well as between or on animplanted first anchor and the delivery device. In this aspect, theneedle assembly acting as a penetrating member can be cooperativelyconnected to a mechanism which produces a desired tension between thevarious anchor members while the needle assembly is retracted. Moreover,this load can be accomplished between first and second implanted anchormembers.

It is to be recognized that various materials are contemplated formanufacturing the disclosed devices. Moreover, one or more componentssuch as distal anchor, proximal anchor, connector, of the one or moreanchor devices disclosed herein may be designed to be completely orpartially biodegradable or biofragmentable.

Further, as stated, the devices and methods disclosed herein may be usedto treat a variety of pathologies in a variety of tubular organs ororgans comprising a cavity or a wall. Examples of such organs include,but are not limited to urethra, bowel, stomach, esophagus, trachea,bronchii, bronchial passageways, veins (e.g. for treating varicose veinsor valvular insufficiency), arteries, lymphatic vessels, ureters,bladder, cardiac atria or ventricles, uterus, fallopian tubes, etc.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

1: A method for treating a prostate involving an anchor delivery deviceincluding a trigger and an extendable element and at least one anchorassembly including a first anchor component, a connector and a secondanchor component, comprising: placing the extendable element at a firstsite; actuating the trigger to advance the first anchor componentthrough the extendable element; retracting the extendable element fromthe first site; employing the anchor delivery device to apply apre-determined tension on the connector; actuating the trigger toassemble the second anchor component to the connector; and releasing thesecond anchor component at a second site. 2: The method of claim 1,wherein the anchor delivery device can be configured to apply a desiredtensile force on the connector. 3: The method of claim 1, furthercomprising: extending the extendable element from an original position;and retracting the extendable element to the original position. 4: Themethod of claim 1, wherein the pre-determined tension is betweenapproximately one-half and approximately 5 pounds of force on theconnector. 5: The method of claim 1, wherein the pre-determined tensionis approximately 1 pound of force on the connector. 6: The method ofclaim 1, wherein the anchor delivery device includes a scope, furthercomprising employing the scope to remotely view prostate treatment. 7:The method of claim 1, further comprising assembling the anchor assemblyto a desired length. 8: The method of claim 1, further comprisingassembling a plurality of anchor assemblies. 9: The method of claim 1,wherein each of the anchor assemblies can have a unique length. 10: Themethod of claim 1, further comprising severing the connector to aselected length. 11: The method of claim 1, wherein the extendableelement is a needle assembly operatively associated with the trigger.12: The method of claim 11, wherein the needle assembly can be advancedto variable, selectable depths within a patient. 13: The method of claim11, wherein placing the extendable element at a desired first siteinvolves varying a depth to which the needle assembly is placed within apatient. 14: The method of claim 13, further comprising deliveringbotulinum toxin to the prostate. 15: The method of claim 13, furthercomprising delivering 100 to 200 units of botulinum toxin dissolved in 4mL of saline to the prostate. 16: The method of claim 15, whereinpreferably 2 mL are injected in each lobe of the prostate. 17: Themethod of claim 13, further comprising delivering botulinum toxin to abladder. 18: The method of claim 13, further comprising delivering 100to 300 units of botulinum toxin dissolved in 10 to 30 mL of saline intoa base of a bladder, the bladder lateral walls and/or trigone. 19: Themethod of claim 1, wherein one or a series of first anchor componentsare initially attached to the connector, an initial engagement betweenthe first anchor and connector being generally coaxial. 20: The methodof claim 19, wherein the second anchor component initially engages theconnector at a generally perpendicular angle to the connector. 21: Asystem for implanting an anchor assembly, comprising: at least oneanchor assembly, the anchor assembly including a first anchor member, asecond anchor member, and a connector joining the first and secondanchor members; and an anchor delivery device, the anchor deliverydevice including a trigger and a tension mechanism that applies adesired tension to the connector; wherein actuation of the triggeraccomplishes gaining access to a first site, deployment of the firstanchor member independently of the second anchor member, and assembly ofthe second anchor member. 22: The system of claim 21, wherein thetension mechanism is configured to supply approximately a one poundforce on the connector. 23: The system of claim 21, wherein the tensionmechanism is configured to supply between approximately one half poundand approximately five pounds of force on the connector. 24: The systemof claim 21, wherein the tension mechanism is configured to apply aselectable tension between approximately a half pound to approximatelyfive pounds of force between the first and second anchor members. 25:The system of claim 21, wherein the tension mechanism is configured tocreate about a one pound force between the first and second anchormembers. 26: The system of claim 21, wherein the tension mechanismapplies the desired tension before assembly of second anchor. 27: Thesystem of claim 21, wherein the tension mechanism applies the desiredtension while assembling the second anchor.